Sectors

Home/ Services/ Engineering, Project Management/ Sectors Engineering, Project ManagementSectors Pharmaceuticals and Medical Devices Sterile Pharmaceuticals Oral Drugs Medium-Molecule API Large-Molecule (Bio) API Regenerative Medicine Food Cosmetics Home Care Products Semiconductors and Electronic Devices Data Centers Chemical Plants Logistics Halal Consulting & Engineering Other Services Consulting Education/Training Support Technical Information Services [add_part part="sidebar-service"]

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Pharmaceuticals and Medical Devices

Home/ Services/ Engineering, Project Management/ Sectors/ Pharmaceuticals and Medical Devices SectorsPharmaceuticals and Medical Devices CM Plus responds to clients’ needs with top-level expertise and technical capabilities in the construction of production facilities in the fields of pharmaceuticals, medical devices, and more. From sterile pharmaceuticals to active pharmaceutical ingredients, regenerative medicine, and medical devices, we have been meeting numerous needs since our founding, from the business planning stage to basic design, construction, and IQ/OQ phases.We flexibly respond to client situations, not only for new construction, but also for expansion, relocation, partial renovations, and technology transfer. Sector Details Our services range from pharmaceuticals (sterile pharmaceuticals, oral drugs, active pharmaceutical ingredients, vaccines, biopharmaceuticals, investigational drugs, and diagnostics) to medical devices, regenerative medicine, and cell therapy.We also provide a wide range of services from R&D facilities to clinical trials, pilot plants, and commercial production. Sterile Pharmaceuticals Oral Drugs Medium-Molecule API Large-Molecule (Biopharmaceutical) API Regenerative Medicine (Consultation Service) Features The pharmaceutical and medical device sectors deal with products that directly impact human health, thus requiring stricter quality control than other products. The characteristics of manufacturing facilities include: Compliance with GMP is required (PIC/S, cGMP, EU-GMP, and GMPs of various countries). Advanced environmental control (cleanliness management, temperature and humidity management, room pressure management, pharmaceutical water management, etc.) is necessary. Advanced hazard management (chemical hazards, biohazards), management of hazardous materials, and management of poisons/narcotics may be required. Since the production equipment and the building/architectural facilities need to function as a cohesive unit, complex integrations between them arise. Proper commissioning and qualification (C&Q) based on accurate risk analysis are required. Keys to Success How to Ensure the Success of Construction Projects in the Pharmaceutical and Medical Device Sectors: From the early planning stages, proceed while consciously including GMP compliance and validation at each step by confirming specifications accurately....

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Sterile Pharmaceutical Manufacturing Facility

Home/ Services/ Engineering, Project Management/ Sectors/ Pharmaceuticals and Medical Devices/ Sterile Pharmaceutical Manufacturing Facility Pharmaceuticals and Medical DevicesSterile Pharmaceutical Manufacturing Facility About Sterile Pharmaceuticals Sterile pharmaceuticals include injectable drugs administered by injection, dialysis agents administered through dialysis, and eye drops administered to the eye. Direct containers in contact with the drug have functions to maintain the quality of the drug and to ensure user convenience. These containers include ampoules, vials, cartridges, infusion bags, pre-filled syringes (PFS), blow-fill-seal (BFS), form-fill-seal (FFS), and plastic containers. Sterile pharmaceuticals are manufactured using either terminal sterilization methods or aseptic processing methods to ensure sterility. When handling various containers such as vials and syringes, the supply form of direct containers called NEST, where pre-washed and sterilized direct containers are set in dedicated cases, is sometimes used. In such cases, devices like filling machines are also dedicated to NEST, but they feature easy container switching. Filled products are packed in single or multiple layers of films or paper, labeled with legally mandated information (such as lot numbers, expiration dates, and GS1 barcodes), and maintain the quality of the product during transportation and prevent errors and ensure convenience during use. Example of a Sterile Pharmaceutical Manufacturing Process The following diagram illustrates the process flow of a vial product using the aseptic method as an example of a sterile pharmaceutical. Example of Process Flow Diagram:Vial Product Using Aseptic Method   Weighing of raw materials, preparation and processes from washing of containers filling/stoppering/sealing, these processes are conducted in a clean room controlled for appropriate particle count, temperature, and humidity to prevent microbial and foreign matter contamination. Particularly, the filling and stoppering processes are performed in grade A cleanliness environments, classified as critical areas. Vials are depyrogenized through a dry heat sterilization tunnel, while rubber stoppers are washed and sterilized using...

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Oral Drugs Facility

Home/ Services/ Engineering, Project Management/ Sectors/ Pharmaceuticals and Medical Devices/ Oral Drugs Facility Pharmaceuticals and Medical DevicesOral Drugs Facility About Oral Pharmaceuticals There are numerous oral preparations taken by mouth, with representative types including tablets, capsules, granules, and powders. Tablets, in particular, can come in forms such as uncoated tablets, film-coated tablets, and sugar-coated tablets. The primary packaging, which directly contacts with the drug, functions to maintain the quality of the drug and ensure user convenience. This primary packaging includes PTP (Press Through Package) blister packaging, strip packaging, sachet packaging, stick packaging, and bottle packaging. Primary packaging products are further wrapped with single or multiple layers of film or paper, carrying regulatory-required labels (such as batch number, expiration date, GS1 barcodes, etc.) to maintain the quality of the product during transportation and prevent errors and ensure convenience during usage. Example of Manufacturing Process for Oral Pharmaceuticals The following diagram illustrates a process flow chart for a film-coated tablet blister package product as an example of an oral formulation. Process Flow Chart Example: Film-Coated Tablet Blister Packaging   The preparation process and primary packaging process are conducted in a clean room where temperature, humidity, and particulate matter are controlled to prevent microbial and foreign matter contamination into the products. During the preparation process, raw materials and intermediate products for each batch are handled using containers between different process stages. Tablets are engraved or printed with the product name or other information. After they are visually inspected, samples are taken for quality testing. Lots that pass the quality tests proceed to primary PTP packaging and secondary packaging as pillow packaging, cartoning, printing & inspection and cardboard packing. Unlike the preparation process, where between each stage requires manual handling, the packaging process is normally fully automated. Lots that pass the final quality tests...

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Medium-Molecule API Manufacturing Facility

Home/ Services/ Engineering, Project Management/ Sectors/ Pharmaceuticals and Medical Devices/ Medium-Molecule API Manufacturing Facility Pharmaceuticals and Medical DevicesMedium-Molecule API Manufacturing Facility Classification Name Low Molecular Weight Medium Molecular Weight High Molecular Weight Molecular Weight ～500 500～2,000 2,000～ Examples Synthetic Organic Pharmaceuticals eptide Pharmaceuticals Nucleic Acid Pharmaceuticals Antibody Drugs Vaccines Main Manufacturing Methods Organic Synthesis Peptide Synthesis Nucleic Acid Synthesis Microbial Culture Animal Cell Culture Medium-Molecule APIs are considered to have a molecular weight of approximately 500 to 2,000. Since the molecular weight of organic synthesis APIs is below 500, and that of APIs produced by microbial or animal cell culture is around 150,000, the former are called Low-Molecule APIs and the latter High-Molecule APIs. The intermediate ones are referred to as middle molecular weight APIs. Medium-Molecule APIs are broadly divided into peptide pharmaceutical APIs and nucleic acid pharmaceutical APIs. Types and Characteristics of Medium-Molecule APIs Peptide Pharmaceutical APIs Peptide pharmaceutical APIs are obtained by synthesizing peptides through solid-phase or liquid-phase reactions that bond 20 types of amino acids. The synthesized peptides need to have the structure of the active sites of proteins that are usually generated in the body. Generally, the peptides are often cyclic to make them less susceptible to degradation and modification. Nucleic Acid Pharmaceutical APIs Nucleic acid pharmaceuticals make use of nucleic acids such as DNA and RNA, which carry genetic information, in medicinal applications. Since nucleic acid pharmaceuticals can be manufactured with synthetic techniques similar to those used for small molecule pharmaceuticals, they can be produced at a lower cost compared to high molecular weight APIs. Moreover, they can target molecules like mRNA and miRNA, which cannot be targeted by either small or high molecular weight pharmaceuticals. Manufacturing Facilities for Middle Molecular Weight APIs ~Key Points in Construction~ Laboratory Scale Facility Adaptation During the drug discovery...

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Large-Molecule ( Biopharmaceutical ) API Manufacturing Facility

Home/ Services/ Engineering, Project Management/ Sectors/ Pharmaceuticals and Medical Devices/ Large-Molecule API Manufacturing Facility Pharmaceuticals and Medical DevicesLarge-Molecule (Biopharmaceutical) API Manufacturing Facility Classification Name Low Molecular Weight Medium Molecular Weight High Molecular Weight Molecular Weight ～500 500～2,000 2,000～ Examples Synthetic Organic Pharmaceuticals eptide Pharmaceuticals Nucleic Acid Pharmaceuticals Antibody Drugs Vaccines Main Manufacturing Methods Organic Synthesis Peptide Synthesis Nucleic Acid Synthesis Microbial Culture Animal Cell Culture Large-Molecule APIs include mainly microbial culture APIs and animal cell culture APIs. These APIs are produced by combining techniques such as genetic recombination, cell banking, cell culture, extraction, and purification to generate the active protein components. Examples include antibodies, enzymes, hormones, and interferons. It is expected that they will address unmet medical needs, which were difficult to address with small molecule pharmaceuticals. Since these APIs involve handling biological organisms and proteins, ensuring the sterility of manufacturing facilities and managing the biological aspects of environmental conditions are necessary. Types and Characteristics of Large-Molecule APIs Materials Used in Large-Molecule (Biological) Pharmaceuticals and Major Pharmaceuticals   Material Major Pharmaceuticals Host Cells Animal Cells CHO, SP2/0, NS0, Human Cells (HT1080, HEK), etc. Blood Coagulation Factors Erythropoietin Antibodies Lysosomal Enzymes Fc Fusion Proteins Microorganisms E. coli Insulin Growth Hormone Interferon Cytokines Enzymes Insulin Glucagon Human Serum Albumin HPV Vaccine Insect Cells HPV Vaccine Plant Cells Rice, Tobacco, Carrot Recombinant Lactoferrin Influenza Vaccine Recombinant Anti-Ebola Virus Antibody Gaucher Disease Treatment Source Cells Animal Heparin Hyaluronic Acid Plant Medicinal Herb Morphine Aspirin Plasma Immunoglobulin Albumin Blood Coagulation Factors Fibrinogen Antithrombin Haptoglobin Orphan Drugs Microbial Culture APIs Microbial cultures can be divided into those that use naturally occurring microorganisms and those that use genetically modified microorganisms. The latter involve engineering microorganisms such as E. coli and yeast to incorporate genes that code for the desired substances (APIs) and then producing (expressing) these substances...

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Food

Home/ Services/ Engineering, Project Management/ Sectors/ Food SectorsFood Do you have these concerns? We lack experienced personnel in factory construction, so we’re unsure where to begin. We are not able to assign the suitable or dedicated personnels for factory construction.。 We want to improve the current situation (KAIZEN). Struggling with how to proceed with construction work? (Cost, delivery time, quality, etc.) Please contact CM Plus We support your project from investment planning and business concept stages. We will materialize clients’ ideas for building a new factory together with clients. CM Plus, as a Construction Manager (CMr), maintains technical neutrality and stands on the side of the client, performing various management tasks such as examining design, advice of construction formation, schedule management, quality control, and cost management during the design, procurement, and construction phases. We, understanding the production process, execute design by developing architectural facilities from within, such as constructing production equipment lines and laying out internal flow lines and logistics. This enables us to propose food factories that are harmonized with production systems. Additionally, we plan for the introduction of the latest technologies, consideration for sustainability, and delve into the intangible aspects of production systems. We propose methods for advancing construction work suitable for your project, without being tied to any specific design, construction company, or production equipment manufacturer at the time of inquiry. Advantage of CM Plus Extensive Experience in Factory Construction CM Plus has a wealth of experience in constructing various factories, including food factories, both domestically and internationally. We standardize the technologies and know-how cultivated from these experiences into our operations, consistently providing high-level services. Additionally, experts familiar with food manufacturing address the challenges faced by clients while executing projects. Facility Planning Focused on Production Equipment CM Plus has an engineering team specialized in production equipment. We...

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Halal Consulting & Engineering

Home/ Services/ Engineering, Project Management/ Sectors/ Halal SectorsHalal Consulting & Engineering From acquisition of Halal certification to design and construction of Halal-certified factories The Muslim market is gaining significant attention from Japanese companies in the food, pharmaceutical, and cosmetics industries. With population growth, increasing interest in Japanese culture, and the development of local supply chains providing ingredients for a growing Muslim market, Halal certification of products and services for target categories has become essential.   Indonesia will implement mandatory Halal certification for food and beverage products starting in October 2024. Malaysia is also strengthening its Halal industry through the Halal Industry Master Plan 2030, which was put into effect in March 2023.   CM Plus has been providing engineering and consultation services for manufacturing facilities in Southeast Asia. In light of the impact of changes in Halal certification on our customers, we have partnered with Halal certification consultants in Indonesia and Malaysia to provide support from acquiring Halal certification to the design and construction of actual Halal-certified factories. Our subsidiaries in Southeast Asia and our Muslim employees provide one-stop support from consultation to design and construction of Halal-compliant factories with professionals in production facility engineering. Do you have any of these concerns? You would like to quickly implement Halal compliance in response to the trend toward mandatory Halal certification. You want to ensure that your factories and products are Halal-compliant, but are unsure what type of manufacturing facilities and management systems you need (for existing factories/new factories and existing products/new products). You are looking for a Halal-compliant manufacturing contractor. You seek a partner who can manage everything from acquiring Halal certification to implementing specific measures for your manufacturing facilities. In CM Plus We offer comprehensive support for Halal certification. Our team is affiliated with overseas Halal specialists and is dedicated to providing...

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Logistics facility

Home/ Services/ Engineering, Project Management/ Sectors/ Logistics Logistics facility Facing any of these challenges? You want to optimize in-plant logistics (intra-facility logistics) to increase productivity. What can CM Plus do to build a better logistics plan? A: CM Plus can It is necessary to put in a warehouse, store, and ship "things" such as raw materials, intermediate materials, and finished products from the manufacturing process at the right time and place. CM Plus will organize the requirements on your behalf and collect the information necessary to create the optimal logistics plan. Within the factory, it is necessary to comprehensively look at the functions of each building, such as the office building, manufacturing building, and warehouse, analyze the flow of goods, logistics volume (people and goods), storage volume, etc., and create a practical and rational layout plan. Confirmation of production conditions - Consideration of factory layout CM Plus document requirements, including production, logistics, and building functions, as a User's Requirement Brief (URB) and create a site master plan. This makes it possible to "visualize" requirements throughout the entire factory planning and construction process, resulting in a factory with efficient logistics. What kind of transport equipment is best for automation and labor saving? A: CM Plus can At the concept creation stage, CM Plus introduce the latest transport equipment and examples of its use to share an image with you. Simaltaneously, compile requirements for linking the logistics management system with ERP and MES. How should you arrange automated transport equipment such as AGVs within the premises? A: CM Plus can When introducing automated transport equipment, CM Plus advise you to consider the transport equipment and the building simultaneously. Type and number of transport devices Corridor width Warehouse capacity Method of delivery to and from production machines Method of managing transport data, etc....

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Cosmetics

Home/ Services/ Engineering, Project Management/ Sectors/ Cosmetics SectorsCosmetics Do you have these concerns? We are considering building a new cosmetics factory; in such case, we are unsure where to start. We are uncertain about how to implement cosmetics GMP. We want to know the rough construction costs for building a cosmetics factory. We are looking to reduce construction costs. Please contact CM Plus We will listen to your as-yet-unformed requirements and compile them into a document called URB (User Requirement Brief). The URB clarifies vague requirements, and it serves as the foundation for advancing the construction plan. We can advise on how much of the industry standard cosmetics GMP, ISO 22716, should be incorporated. Based on our extensive experience in applying pharmaceutical GMP to pharmaceutical factories, CM Plus will provide appropriate advice that captures the essence of GMP. At the end of the basic planning and basic design phases, we will present you with the approximate construction costs. Upon completion of the basic design, we recommend requesting quotations from multiple construction companies. Advantage of CM Plus Facility Planning Focused on Production Equipment CM Plus not only has first-class architects but also a wide range of specialized engineers including process engineers, mechanical engineers, electrical and instrumentation engineers, and HVAC engineers. Additionally, we have numerous project managers with extensive experience in project execution. This enables us to support not only building construction but also internal equipment layout and procurement of cosmetics manufacturing equipment. Compliance with Regulations and Guidelines CM Plus have a wealth of consultants and engineers who are thoroughly familiar with GMP for pharmaceutical factories, enabling us to provide advice on the application of cosmetics GMP to our clients. Estimation of Costs at the Basic Planning At the end of the basic planning phase, we use CM Plus’ construction cost databank...

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